sible. You have to keep building proto-types, running tests for three months,then do it all over and over, until theproduct meets your goals. That does notallow much time for innovations. If youcan do the same thing on the computerin three days, now you can create up-dates, optimize, and wind up with muchbetter products.”“Most medical device companiescreate their devices on computers usingour design software so they already havedigital models. What they don’t have isa digital model of the patient environ-ment, in this case a beating heart. If theysupply a digital model of their device, wecan now send their device back to themoperating inside of a beating heart. Anycustomer can access the tools from theirbrowser. Using the cloud, they can puttheir device into a heart model and testit virtually, altering the design as the seeits performance as well as varying thepatient disease state.

Aiding certification

As mentioned earlier, the FDA is involved in this project. For the foreseeable
future, animal studies and human trials
will still be required for certification of
new drugs and medical devices. However, technologies like the Living Heart can
streamline the time-to-certification and
increase confidence in the result.

“The FDA calls it ‘Evidence’,” Levinesays. “They have said publicly that in thefuture they expect as much as 50 percentof all Evidence will come from computermodels. That’s one of the reasons theyjoined this project. They believe thatit can help them assure safety whilereducing regulatory cost. They under-stand that what we do is not just presentthe results; we can evaluate exactly howany device works, fails, how the heartactually reacts. While we can’t predicteverything, we can provide much moreinformation than from current sourcesof Evidence available today. This candramatically reduce the amount of trialdata needed.”“As an example, we help developersdesign a clinical trial so they will getthe right answer. In one particular case,a developer was looking at pacemakerleads that go into the heart and deliveran electrical charge.”“These are metal wires. The heartbeats millions of times and as we know,metal bends and can break. Theywanted a standard for how they mea-sure that fatigue point when implantedin a human heart. Because this was anunknown, they didn’t know what toregulate, so they really didn’t have anyformal standard for it. We ran a virtual